HypertensionEPICNCT05638009
The ECLA/PHRI Intervention in the Community Trial
A study testing Salt substitute 66%33% and Salt substitute 33%/66% in people with Hypertension, run by Estudios Clínicos Latino América at 1 site in Argentina.
Trial summary
EPIC is a cluster-randomized, double-blind trial to evaluate the effect of two potassium-enriched salt substitute preparations (one available in the Argentine market and one derived from it), compared to regular salt on systolic blood pressure in subjects ≥ 18 and ≤ 90 years old from Rosario department households in… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Salt substitute 66%33% and Salt substitute 33%/66%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,490 participants
- Where
- 1 siteArgentina
- Study dates
- 14 Nov 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects ≥ 18 and ≤ 90 years old will be included, with no specific clinical conditions from households that meets the following criteria:
- The household must be composed of at least 2 individuals
- At least 1 of the individuals included must be over 40 years of age
- The household must be located in Rosario department, Santa Fe province, Argentina
Who cannot join
- Households will be excluded if a any household member has a at least one of the following contraindication to the salt substitute used in the trial:
- use of a potassium-sparing diuretic
- use of a potassium supplement
- known history of hyperkalemia
- use of salt reduced in sodium and enriched in potassium by medical indication
- do not consume any type of salt for medical indication
Show all 11Show fewer
- known primary or secondary hyperaldosteronism
- known severe kidney disease (routine biochemical measurement of kidney function will not be performed in household members not included in the study).
- Pregnancy or lactation
- Evidence of hyperkalemia and/or a creatinine clearance (calculated through the CKD-EPI formula <30 ml/min/1.73m2) in baseline blood laboratory. For those participants who consent to be tested, blood sample will be used. For those participant who has a laboratory test performed with those biomarkers in the past 6 months those results will be considered
- Households in which any of the study participants consume more than 50% of their meals prepared outside their home will also be excluded.
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
IIC-Instituto de Investigaciones Clínicas
Rosario, Santa Fe Province, 2000
About this study
Official title: The ECLA/PHRI Intervention in the Community Trial - EPIC Trial
EPIC is a cluster-randomized, double-blind trial to evaluate the effect of two potassium-enriched salt substitute preparations (one available in the Argentine market and one derived from it), compared to regular salt on systolic blood pressure in subjects ≥ 18 and ≤ 90 years old from Rosario department households in Santa Fe Province, Argentina.
Read the detailed description
The effect of reduced sodium salt preparations has been evaluated in clinical studies (observational and randomized clinical trials) and in meta-analyses, and although a reduction in blood pressure was observed, they have particular characteristics that make them difficult to extrapolate their results to Western populations.
In one of these trials, conducted in rural Indian hypertensive patients, the use of a salt substitute of 75% sodium chloride and 25% potassium chloride showed a significant reduction of systolic blood pressure with a mean difference of -4.58 mmHg in 3 months from baseline to the end of the trial.
Recently, a large cluster-randomized trial conducted in 600 villages in rural areas of five provinces of China (SSaSS trial) among patients with a history of stroke or 60 years of age or elder with elevated blood pressure showed that stroke rates, major cardiovascular events and death from any cause were significantly lower with a salt substitute than with regular salt. The salt substitute used in this trial had 1/3 less sodium than regular salt and substantially more potassium. Therefore, the salt substitute led to an 8% less sodium intake but a 50% higher intake in potassium. This suggests that the greatest impact of salt substitution in this RCT may have been due to an increase in potassium intake rather than the modest decrease in sodium intake that was associated with an average reduction of 2.65 mmHg for SBP (-4.32 to -0.97) and +0.30 mmHg (-0.72 to +1.32) for DBP. In addition, the mean sodium intake in the studied population in this trial was approximately 4.2 gr/d, which is higher than the global average worldwide sodium consumption of 3.9 gr/d. In contrast, potassium intake was lower than the average global potassium intake. Therefore, several considerations that limit the applicability to other populations remain unresolved. The sodium intake of the Chinese rural population is higher than in many other countries, while the potassium intake is relatively low. In addition, in many countries commercially available foods may have added sodium chloride for preservation and thus increase the amount of sodium to the diet. Therefore, the use of salt substitutes would not fully account for salt intake in most cases. Finally, Chinese social and environmental features may be somewhat different to most western countries.
EPIC's investigators stated the hypothesis that salt substitutes could lower systolic blood pressure in a dose-response mode. Therefore, they propose to conduct a randomized cluster trial to evaluate the effect of consuming two doses enriched potassium salt substitutes preparations compared to regular salt intake on systolic blood pressure in individuals from Rosario department.
- Conditions
- Hypertension
- Being tested
- Salt substitute 66%33%, Salt substitute 33%/66%
- Keywords
- Sodium Chloride, Dietary
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salt substitute 66%33%Dietary supplement
Salt substitute composed of 66% potassium chloride and 33% sodium chloride
Salt substitute 33%/66%Dietary supplement
Salt substitute composed of 33% potassium chloride and 66% sodium chloride
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | regular salt (99% sodium chloride) |
| Salt substitute 1 | Experimental | Salt substitute 1 is a potassium-enriched salt substitute composed of 66% potassium chloride and 33% sodium chloride Receives: Dietary Supplement: Salt substitute 66%33% |
| Salt substitute 2 | Experimental | Salt substitute 2 is a potassium-enriched salt substitute composed of 33% potassium chloride and 66% sodium chloride Receives: Dietary Supplement: Salt substitute 33%/66% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic Blood Pressure at day 120
Systolic Blood Pressure will be measured by a standardized automated device
Measured: 120 days
Secondary outcomes (4)
Hyperkalemia
Evidence of Hyperkalemia is determined by clinical suspicion or biochemical value defined as a serum potassium value above 5.5 mmol/l (in case it is measured) during the follow up.
Measured: 120 days
Salt substitutes acceptance and incorporation into the diet
Salt substitutes acceptance and incorporation into the diet will be measured through a questionnaire administrated at 30 days and follow-up.
The questionnaire includes the following questions: How many days in the last week did you use study salt? If you were meant to use the study salt in the last week but did not use it every day, what is the reason? If you use the study salt in the last week: How did you use it? How many meals did you use the study salt during the day? Did you enjoy the taste? (1 = disliked a lot; 10 = liked a lot)
Measured: 120 days
Diastolic Blood Pressure at day 120
Diastolic Blood Pressure will be measured by a standardized automated device
Measured: 120 days
Mean arterial pressure (MAP) at day 120
Systolic and Diastolic Blood Pressure will be measured by a standardized automated device in order to compute MAP
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start14 Nov 2022
- Primary completion14 Apr 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2,490 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Estudios Clínicos Latino América
- Sponsor type
- University, hospital or other
- Collaborators
- Population Health Research Institute
- Responsible party
- Sponsor
- Investigators
- María Luz Diaz, MD, Principal investigator, ECLA- Estudios Clínicos Latino América
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05638009
- Sponsor's protocol ID
- EPIC. Version 2.0
- Acronym
- EPIC
- Status last verified
- Dec 2022
- First submitted
- 25 Nov 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The ECLA/PHRI Intervention in the Community Trial - EPIC Trial
- ClinicalTrials.gov ID
- NCT05638009
- Acronym / sponsor ID
- EPIC / EPIC. Version 2.0
- Conditions
- Hypertension
- Keywords
- Sodium Chloride, Dietary
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,490 participants (estimated)
- Lead sponsor
- Estudios Clínicos Latino AméricaUniversity, hospital or other
- Collaborators
- Population Health Research Institute
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 14 Apr 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
EPIC is a cluster-randomized, double-blind trial to evaluate the effect of two potassium-enriched salt substitute preparations (one available in the Argentine market and one derived from it), compared to regular salt on systolic blood pressure in subjects ≥ 18 and ≤ 90 years old from Rosario department households in Santa Fe Province, Argentina.
Detailed description
The effect of reduced sodium salt preparations has been evaluated in clinical studies (observational and randomized clinical trials) and in meta-analyses, and although a reduction in blood pressure was observed, they have particular characteristics that make them difficult to extrapolate their results to Western populations.
In one of these trials, conducted in rural Indian hypertensive patients, the use of a salt substitute of 75% sodium chloride and 25% potassium chloride showed a significant reduction of systolic blood pressure with a mean difference of -4.58 mmHg in 3 months from baseline to the end of the trial.
Recently, a large cluster-randomized trial conducted in 600 villages in rural areas of five provinces of China (SSaSS trial) among patients with a history of stroke or 60 years of age or elder with elevated blood pressure showed that stroke rates, major cardiovascular events and death from any cause were significantly lower with a salt substitute than with regular salt. The salt substitute used in this trial had 1/3 less sodium than regular salt and substantially more potassium. Therefore, the salt substitute led to an 8% less sodium intake but a 50% higher intake in potassium. This suggests that the greatest impact of salt substitution in this RCT may have been due to an increase in potassium intake rather than the modest decrease in sodium intake that was associated with an average reduction of 2.65 mmHg for SBP (-4.32 to -0.97) and +0.30 mmHg (-0.72 to +1.32) for DBP. In addition, the mean sodium intake in the studied population in this trial was approximately 4.2 gr/d, which is higher than the global average worldwide sodium consumption of 3.9 gr/d. In contrast, potassium intake was lower than the average global potassium intake. Therefore, several considerations that limit the applicability to other populations remain unresolved. The sodium intake of the Chinese rural population is higher than in many other countries, while the potassium intake is relatively low. In addition, in many countries commercially available foods may have added sodium chloride for preservation and thus increase the amount of sodium to the diet. Therefore, the use of salt substitutes would not fully account for salt intake in most cases. Finally, Chinese social and environmental features may be somewhat different to most western countries.
EPIC's investigators stated the hypothesis that salt substitutes could lower systolic blood pressure in a dose-response mode. Therefore, they propose to conduct a randomized cluster trial to evaluate the effect of consuming two doses enriched potassium salt substitutes preparations compared to regular salt intake on systolic blood pressure in individuals from Rosario department.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –regular salt (99% sodium chloride) |
| Salt substitute 1 | Experimental | Dietary Supplement: Salt substitute 66%33%Salt substitute 1 is a potassium-enriched salt substitute composed of 66% potassium chloride and 33% sodium chloride |
| Salt substitute 2 | Experimental | Dietary Supplement: Salt substitute 33%/66%Salt substitute 2 is a potassium-enriched salt substitute composed of 33% potassium chloride and 66% sodium chloride |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects ≥ 18 and ≤ 90 years old will be included, with no specific clinical conditions from households that meets the following criteria:
- The household must be composed of at least 2 individuals
- At least 1 of the individuals included must be over 40 years of age
- The household must be located in Rosario department, Santa Fe province, Argentina
Key exclusion criteria (11 listed)
- Households will be excluded if a any household member has a at least one of the following contraindication to the salt substitute used in the trial:
- use of a potassium-sparing diuretic
- use of a potassium supplement
- known history of hyperkalemia
- use of salt reduced in sodium and enriched in potassium by medical indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salt substitute 66%33%Salt substitute composed of 66% potassium chloride and 33% sodium chloride | Dietary supplement | Salt substitute 1 |
| Salt substitute 33%/66%Salt substitute composed of 33% potassium chloride and 66% sodium chloride | Dietary supplement | Salt substitute 2 |
Primary outcome
Systolic Blood Pressure at day 120
Time frame: 120 days
Systolic Blood Pressure will be measured by a standardized automated device
4 secondary outcomes
Hyperkalemia
Time frame: 120 days
Salt substitutes acceptance and incorporation into the diet
Time frame: 120 days
Diastolic Blood Pressure at day 120
Time frame: 120 days
Mean arterial pressure (MAP) at day 120
Time frame: 120 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
Related trials for Hypertension
Not yet recruiting
PAUL® Glaucoma Implant Safety and Effectiveness Study
Refractory Glaucoma
RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Recruiting
Dry Weight Reduction Intervention Via Extra Ultrafiltration
Fluid Accumulation, Blood Pressure Management
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
María Luz Diaz, MD principal investigator
ECLA- Estudios Clínicos Latino América
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Salt substitute 66%33% and Salt substitute 33%/66% in people with Hypertension, run by Estudios Clínicos Latino América at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact María Luz Diaz, MD (+54 9 341605-3295, marialuzdiaz02@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic Blood Pressure at day 120 (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.